Policy & Regulation
Dynavax's CpG 1018 adjuvant meets both co-primary endpoints in Phase 3 COV-COMPARE trial
18 October 2021 -

Biopharmaceutical company Dynavax Technologies Corporation (Nasdaq:DVAX) on Monday provided an update from Valneva SE's positive topline results from the Phase 3 pivotal trial of the inactivated COVID-19 vaccine candidate VLA2001 using Dynavax's CpG 1018 adjuvant.

The Cov-Compare (VLA2001-301) is a randomized, observer-blind, controlled, comparative immunogenicity trial in 4,012 adults and 660 adolescents. The trial is being conducted at 26 sites across the UK. About 2,972 participants 30 years of age and older were randomized in a 2:1 ratio to receive two intramuscular doses of either VLA2001 or AZD1222 at the recommended dose level, 28 days apart.

Additionally, CpG 1018 is the adjuvant used in HEPLISAV-B. Dynavax developed CpG 1018 adjuvant to provide an enhanced vaccine immune response, which has been demonstrated in HEPLISAV-B and in multiple COVID-19 vaccine candidates. CpG 1018 adjuvant provides well- developed technology and safety database, supporting development and large-scale manufacturing of a COVID-19 vaccine.

According to the company, VLA2001 successfully met both co-primary endpoints. Its superior neutralizing antibody titer levels were compared to active comparator vaccine, AstraZeneca's AZD1222 (ChAdOx1-S). Its neutralizing antibody seroconversion rate was above 95%. VLA2001 was well-tolerated, demonstrating a statistically significant better tolerability profile compared to active comparator vaccine.

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